Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Intended Purpose and Classification

(i) what is detected and/or measured; (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic); (iii) the specific information that is intended to be provided in the context of: • — a physiological or pathological state; • — congenital physical or mental impairments; • — the predisposition to a medical condition or a disease; • — the determination of the safety and compatibility with potential recipients; • — the prediction of treatment response or reactions; • — the definition or monitoring of therapeutic measures;

Scientific Validity

Commercial Implications

Clinical Performance

Intended Purpose

Risk Management

Classification

Liability

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Intended Purpose and Classification

• Example 1.

Option 1. This is a CLIA for the measurement of hCG concentrations for the diagnosis of pregnancy.

Class B – Rule 6

Option 2. This is a CLIA for the measurement of hCG concentrations for the diagnosis of pregnancy and as an aid in the diagnosis of testicular cancer.

Class C – Rule 3.h

In Option 1, the use for cancer diagnosis it foreseeable misuse: disclaimer required

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